Intravenous AccessNCT05204082
A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children
A study testing Single Use Vein Entry Indicator Device in people with Intravenous Access, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Access
- What is being tested?
- Single Use Vein Entry Indicator Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient age < 18 years old.
- Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
- Written informed consent/ assent from the patient or legal guardian.
Who cannot join
- Patient age > 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.
- Conditions
- Intravenous Access
- Being tested
- Single Use Vein Entry Indicator Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Use Vein Entry Indicator DeviceDevice
Also called SU-VEID
Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Standard IV Insertion | No intervention | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion |
| SU-VEID assisted IV Insertion | Other | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device Receives: Device: Single Use Vein Entry Indicator Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With IV Access at First Attempt
Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start28 Mar 2022
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Why it stopped: The available SU-VEID devices expired and unable to acquire additional devices for study completion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intravenous AccessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Nemergut, Mayo Clinic
- Investigators
- Michael Nemergut, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204082
- Sponsor's protocol ID
- 21-006822
- Status last verified
- May 2024
- First submitted
- 10 Jan 2022
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children
- ClinicalTrials.gov ID
- NCT05204082
- Acronym / sponsor ID
- 21-006822
- Conditions
- Intravenous Access
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The available SU-VEID devices expired and unable to acquire additional devices for study completion.
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 23 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard IV Insertion | No intervention | –Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion |
| SU-VEID assisted IV Insertion | Other | Device: Single Use Vein Entry Indicator DevicePediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient age < 18 years old.
- Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
- Written informed consent/ assent from the patient or legal guardian.
Key exclusion criteria (1 listed)
- Patient age > 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Use Vein Entry Indicator DeviceAlso: SU-VEIDElectronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. | Device | SU-VEID assisted IV Insertion |
Primary outcome
Percentage of Participants With IV Access at First Attempt
Time frame: Baseline
Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Nemergut, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Use Vein Entry Indicator Device in people with Intravenous Access, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With IV Access at First Attempt (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.